]>
IRCT20241122063802N1 IRCT 2025-02-09 Tabriz University of Medical Sciences Efficacy of Parasacral Transcutaneous Electrical Nerve Stimulation in the Treatment of Patients with Overactive Bladder Syndrome: A Single Blinded Randomized Controlled Trial Efficacy of Parasacral Transcutaneous Electrical Nerve Stimulation in the Treatment of Patients with Overactive Bladder Syndrome: A Single Blinded Randomized Controlled Trial 2025-02-19 anticipated 75 Complete https://irct.ir/trial/80981 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients with overactive bladder will be randomly assigned to two separate groups using a method called Balanced Block Randomization. This method allows for random assignment in such a way that the study groups are balanced in terms of baseline characteristics, clinical variables, and all potential confounding variables. In this study, the number of blocks will be ... and the size of each block will consist of 4 patients. Essentially, the arrangement within each block indicates the type of group/intervention for each patient. Random allocation was performed using STATA software version 14 by an epidemiologist. The list of blocks and their random allocation order is attached in the Excel file (Rand), Blinding description: This study will be conducted as a randomized, single-blind, controlled clinical trial. Participants will include at least 75 patients diagnosed with overactive bladder, who will be randomly assigned by a methodologist (who will have no role in the final analysis) at the Al-Zahra Clinical Trial Center in Tabriz to one of three treatment groups: parasacral treatment, TENS, SHAM, and pharmacological treatment. The study will be blinded for the providers assessing the outcomes, while those administering the treatments will be aware of the type of treatment being given. Randomization will be carried out using a sealed, opaque envelope. N/A Overactive bladder. Intervention 1: Intervention group: Intervention 1) Pelvic Floor Exercises This intervention will be the same for all groups to ensure that neither group is deprived of primary and supportive treatment. Both groups in the study will use pelvic floor muscle strengthening exercises following the protocol below. The exercises will follow the Progressive Supervised Pelvic Floor Muscle Training (PFMD) protocol, consisting of three sets throughout the day, with each set including three exercises and ten repetitions of each exercise for a duration of 6 to 8 weeks. Intervention 2) Parasacral Electrical Stimulation In this study, a device will be used for Transcutaneous Electrical Nerve Stimulation (TENS). Two surface electrodes, 3.5 centimeters in size, will be placed on each side of S3 and S2. The electrical energy will be generated by a generator. This method will consist of 24 TENS sessions. TENS will be performed three times a week for 8 weeks, with each session lasting 20 minutes. The frequency used will be 10 Hz, with pulse durations of 500-700 microseconds. The current intensity will be increased to the maximum level tolerable by the individual. In the experimental group, only the active parasacral electrodes will be used, while in the SHAM group, the device will be connected similarly without establishing current flow. Intervention 2: Control group: Intervention 1) Pelvic Floor Exercises This intervention will be the same for both groups to ensure that neither group is deprived of primary and supportive treatment. Both groups in the study will use pelvic floor muscle strengthening exercises following the protocol below. The exercises will follow the Progressive Supervised Pelvic Floor Muscle Training (PFMD) protocol, consisting of three sets throughout the day, with each set including three exercises and ten repetitions of each exercise for a duration of 6 to 8 weeks. Intervention 3: Intervention group: Mirabegron therapy group: Participants will receive a standard dose of Mirabegron (50 mg) daily.". Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Based on the survey of patients, their data will be published anonymously if they consent.
public Reza Sattarpour
Al-Zahra Educational and Treatment Center, Baghshamal Intersection, South Army Street
Tabriz Iran (Islamic Republic of) 5138663134 +98 41 3553 9161 rezasattarpour.tums@gmail.com Tabriz University of Medical Sciences scientific Reza Sattarpour
Al-Zahra Educational and Treatment Center, Baghshamal Intersection, South Army Street
Tabriz Iran (Islamic Republic of) 5138663134 +98 41 3553 9161 rezasattarpour.tums@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Individuals aged 18 or older with Overactive Bladder (OAB) who have experienced urinary urgency, frequency (more than eight times a day), nocturia (waking up more than twice at night), and/or urgency urinary incontinence (an average of eight or more urinations in 24 hours and three or more urgencies, with severity levels of 3—severe urgency or 4—urgency incontinence) with or without incontinence over a period of three days. Participants must have experienced symptoms for at least three months and provide informed consent. 18 years 75 years Female - Individuals with neurological disorders affecting bladder function - Patients currently receiving other medications for OAB or those who have recently undergone bladder surgery. Pregnant or breastfeeding women Individuals with stress or mixed incontinence Presence of a urinary catheter Evidence of a symptomatic urinary tract infection, chronic bladder inflammation, or stones Previous pelvic radiation therapy, or current malignancy Patients with implanted electronic devices (such as pacemakers) Those with active skin infections or lesions at the electrode placement site. Individuals with epilepsy or a history of seizures Patients with severe cardiac conditions or other serious systemic diseases High blood pressure is defined as systolic blood pressure (SBP) greater than 180 mmHg or diastolic blood pressure (DBP) greater than 110 mmHg. N32.81 Overactive bladder Treatment - Other Treatment - Other Treatment - Drugs Intervention group: Intervention 1) Pelvic Floor Exercises This intervention will be the same for all groups to ensure that neither group is deprived of primary and supportive treatment. Both groups in the study will use pelvic floor muscle strengthening exercises following the protocol below. The exercises will follow the Progressive Supervised Pelvic Floor Muscle Training (PFMD) protocol, consisting of three sets throughout the day, with each set including three exercises and ten repetitions of each exercise for a duration of 6 to 8 weeks. Intervention 2) Parasacral Electrical Stimulation In this study, a device will be used for Transcutaneous Electrical Nerve Stimulation (TENS). Two surface electrodes, 3.5 centimeters in size, will be placed on each side of S3 and S2. The electrical energy will be generated by a generator. This method will consist of 24 TENS sessions. TENS will be performed three times a week for 8 weeks, with each session lasting 20 minutes. The frequency used will be 10 Hz, with pulse durations of 500-700 microseconds. The current intensity will be increased to the maximum level tolerable by the individual. In the experimental group, only the active parasacral electrodes will be used, while in the SHAM group, the device will be connected similarly without establishing current flow. Control group: Intervention 1) Pelvic Floor Exercises This intervention will be the same for both groups to ensure that neither group is deprived of primary and supportive treatment. Both groups in the study will use pelvic floor muscle strengthening exercises following the protocol below. The exercises will follow the Progressive Supervised Pelvic Floor Muscle Training (PFMD) protocol, consisting of three sets throughout the day, with each set including three exercises and ten repetitions of each exercise for a duration of 6 to 8 weeks. Intervention group: Mirabegron therapy group: Participants will receive a standard dose of Mirabegron (50 mg) daily." ICIQ-OAB Score: A 4-item questionnaire with a score range of 0-16, where higher scores indicate greater severity of overactive bladder symptoms.Mild OAB: Total score of 5 or lessModerate OAB: Total score between 6 and 11Severe OAB: Total score of 12 or more. Timepoint: Initially, 2 months and 4 months after treatment. Method of measurement: Using the valid and reliable Persian ICIQ-OAB questionnaire. The score of the ICIQ-UI SF questionnaire: It is a 4-item questionnaire with a scoring range of 0-21. This questionnaire is used to evaluate the frequency, severity, and impact on quality of life of urinary incontinence in men and women in research and clinical practice worldwide. 0: No urinary incontinence exists. 1-5: Mild incontinence; may not have a significant impact on quality of life. 6-12: Moderate incontinence; likely affects daily activities. 13-21: Severe incontinence; has a significant impact on quality of life and daily functioning. Timepoint: Initially, 2 months and 4 months after treatment. Method of measurement: Using the valid and reliable Persian ICIQ-UI SF questionnaire. The LUTS-QoL questionnaire score: A 20-item questionnaire for evaluating the quality of life in individuals with urinary incontinence. The minimum and maximum scores on this questionnaire are 19 and 76, respectively, with lower scores indicating better quality of life. Timepoint: Initially, 2 months and 4 months after treatment. Method of measurement: Using the valid and reliable Persian LUTS-QoL questionnaire. The Female Sexual Function Index (FSFI) is a valid 19-question questionnaire that evaluates female sexual function in six domains. Higher scores indicate better sexual function. The total FSFI score is calculated by summing the scores of individual domains, with a maximum possible score of 36. Scores below 26.55 are typically considered indicative of sexual dysfunction. Timepoint: Initially, 2 months and 4 months after treatment. Method of measurement: Using the valid and reliable Persian FSFI questionnaire. The Voiding Diary form contains information such as the number of urination instances, the volume of urine passed, and the volume of fluids consumed by the patient over a period of at least 24 hours. The Voiding Diary form will be given to patients and they will be asked to complete it 72 hours before starting treatment (before the first therapy session) and 72 hours after completing treatment (after the last therapy session). Timepoint: Initially, 2 months and 4 months after treatment. Method of measurement: Using the valid and reliable Persian Voiding diary. The occurrence and severity of any side effects related to treatment with parasacral TENS will be recorded and evaluated at the same time intervals (initially, 3 months, and 6 months after treatment). Therefore, the primary outcome of this study is the change in the severity of OAB symptoms, which will be measured using standard tools. Secondary outcomes will also include changes in quality of life and the occurrence of potential side effects resulting from the treatment. Timepoint: Initially and at 2 and 4 months after treatment. Method of measurement: The treatment is defined using treatment-emergent adverse events (TEAEs). A TEAE is defined as a side effect that begins after the start of the experimental drug treatment; or if the event has been ongoing from the beginning and has become serious, it is related to the experimental drug or has resulted in death, discontinuation, interruption, or reduction of the experimental treatment. Tabriz University of Medical Sciences Approved 2025-01-13 Ethics committee of Tabriz University of Medical Sciences Azadi Street Golgasht Street Central Building of the University of Medical Sciences Tabriz East Azarbaijan Iran (Islamic Republic of)